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Effect of tDCS on Postural Control of Children With DCD

Primary Purpose

Developmental Coordination Disorder

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Coordination Disorder focused on measuring Developmental coordination disorder, Postural balance, Transcranial Direct Current Stimulation, Children, Child Development

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children of both sex, aged between seven years 0 months and 10 years and 11 months;
  • Assent of the child by the Term of Assent and acceptance of parents and / or guardians to participate in the study by signing the Free and Informed Consent Form;
  • Children with DCD indicative according to DSM-5 presenting Percentile <15 in the MABC-2 Motor Evaluation Battery and in the balance domain; and the score indicated for each age by the Developmental Coordination Disorder Questionnaire DCDQ-Brazil (TDC Group).
  • Children without DCD presenting Percentile ≥ 50 in the total score and in the MABC-2 Motor Assessment Battery Balance domain, without indicative by DCDQ (Control Group - GC).
  • Absence of intellectual disability considering performance above the 25th percentile on the RAVEN Color Progressive Matrix scale
  • Absence of visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except ADHD and language disorder because they are the most comorbid disorders with DCD).

Exclusion Criteria:

• Signs of excessive discomfort during or after any procedures or sessions involved in the research.

Sites / Locations

  • Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Sham Comparator

Arm Label

Anodal tDCS (M1)

Anodal Cerebellar tDCS

Cathodal Cerebellar tDCS

Sham tDCS

Arm Description

tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes

tDCS applied over the cerebellum. Dose: 1mA, 20 minutes

tDCS applied over the cerebellum. Dose: 1mA, 20 minutes

tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON)

Outcomes

Primary Outcome Measures

Change from COP - AP axis
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters
Change from COP - ML axis
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters
Change from COP - area
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²)

Secondary Outcome Measures

Full Information

First Posted
March 25, 2019
Last Updated
August 3, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03892083
Brief Title
Effect of tDCS on Postural Control of Children With DCD
Official Title
Effect of Transcranial Direct Current Stimulation (tDCS) on Postural Control of Children With Developmental Coordination Disorder: a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates the effects of Transcranial Direct Current Stimulation (tDCS) on postural control of children with Developmental Coordination Disorder (DCD). All participants will receive four conditions of stimulation, in a crossover protocol: cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS.
Detailed Description
Developmental Coordination Disorder (DCD) is a highly frequent neurodevelopmental disorder with negative impacts on children's motor repertoire, quality of life and general health. One of the main problems faced is the balance deficit, which although well characterized in this population, little is known about the etiological core of this impairment. The cerebellum appears to be a functionally impaired structure in DCD, but frontal motor areas are also involved. Transcranial Direct Current Stimulation (tDCS) is a noninvasive way of inducing local-specific polarity-dependent synaptic modulation. Cerebellar tDCS (CE-tDCS) is even more recent, with still unclear results on its effects on postural balance, with only one study in children, which requires us to better understand the type of stimulation necessary to induce balance improvement in children with DCD. Thus, the investigators aimed to verify the effects of anodal tDCS over primary motor cortex (M1-atDCS) and CE-tDCS (anodic, cathodic and sham) on the balance of children with DCD, compared to children without DCD. METHODS: Fifteen children with DCD (total MABC-2 and balance <15%, with DCDQ positive / TL positive) and 15 children without DCD (MABC-2 total and balance ≥50% and DCDQ negative) will be assessed by platform stabilometry (PS) before and after receiving M1, cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS (crossover). They will be evaluated under conditions without proprioceptive manipulation (direct on PS) with open and closed eyes, and with proprioceptive manipulation (on foam surface) with open and closed eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
Keywords
Developmental coordination disorder, Postural balance, Transcranial Direct Current Stimulation, Children, Child Development

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS (M1)
Arm Type
Active Comparator
Arm Description
tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes
Arm Title
Anodal Cerebellar tDCS
Arm Type
Experimental
Arm Description
tDCS applied over the cerebellum. Dose: 1mA, 20 minutes
Arm Title
Cathodal Cerebellar tDCS
Arm Type
Experimental
Arm Description
tDCS applied over the cerebellum. Dose: 1mA, 20 minutes
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON)
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
Primary Outcome Measure Information:
Title
Change from COP - AP axis
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Title
Change from COP - ML axis
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Title
Change from COP - area
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²)
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Adverse effects will be evaluated using structured questionnaire. Active collection uses a questionnaire with records of the duration (minutes or hours) and intensity (Numerical Rating Scale 0-10) of adverse symptoms reported by the patient. Complaints: Headache Scalp pain Tingling Itching Redness Burning sensations Sleepiness Trouble concentrating Nausea Mood change
Time Frame
Immediately after tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children of both sex, aged between seven years 0 months and 10 years and 11 months; Assent of the child by the Term of Assent and acceptance of parents and / or guardians to participate in the study by signing the Free and Informed Consent Form; Children with DCD indicative according to DSM-5 presenting Percentile <15 in the MABC-2 Motor Evaluation Battery and in the balance domain; and the score indicated for each age by the Developmental Coordination Disorder Questionnaire DCDQ-Brazil (TDC Group). Children without DCD presenting Percentile ≥ 50 in the total score and in the MABC-2 Motor Assessment Battery Balance domain, without indicative by DCDQ (Control Group - GC). Absence of intellectual disability considering performance above the 25th percentile on the RAVEN Color Progressive Matrix scale Absence of visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except ADHD and language disorder because they are the most comorbid disorders with DCD). Exclusion Criteria: • Signs of excessive discomfort during or after any procedures or sessions involved in the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata H Hasue, pHD
Organizational Affiliation
Faculty of Medicine, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil

12. IPD Sharing Statement

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Effect of tDCS on Postural Control of Children With DCD

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